Product code JDR: 510(k) clearances and predicates
Product code JDR covers TMC Compression Implant System. FDA lists 233 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
233 clearances on file under product code JDR. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 5 |
| 2023 | 9 |
| 2024 | 4 |
| 2025 | 3 |
| 2026 so far | 2 |
Recent clearances
Newest JDR clearances in the FDA index, with applicant and decision date:
- K262451, Arthrex DynaNite Staples, applicant Arthrex, Inc., decided 2026-09-01. FDA record
- K261121, Megalodon Dynamic Compression System, applicant Paragon 28, Inc., decided 2026-08-06. FDA record
- K250712, Linkt Compression Staple System, applicant Trax Surgical, decided 2025-05-14. FDA record
- K243888, Medline UNITE® REFLEX® Hybrid Nitinol Implant System, applicant Medline Industries, LP, decided 2025-04-11. FDA record
- K243742, Arthrex DynaNite Nitinol Staples, applicant Arthrex, Inc., decided 2025-01-31. FDA record
- K243658, TMC Compression Implant System, applicant Treace Medical Concepts, decided 2024-12-26. FDA record
- K242415, TMC Compression Implant System, applicant Treace Medical Concepts, decided 2024-09-06. FDA record
- K240212, COGNiTiON Staple System, applicant Ortho Solutions UK , Ltd., decided 2024-02-23. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Arthrex DynaNite Staples, Megalodon Dynamic Compression System. Watch new JDR clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code JDR?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JDR clearances include TMC Compression Implant System.
How many 510(k) clearances use product code JDR?
233 at the time this page was generated, from openFDA records.
How do I find a predicate device under JDR?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new JDR clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.